Kornimate/medical-research-clean huggingface dataset:
non-interventional study to assess the effectiveness and safety of ribociclib in the adjuvant therapy of hormone receptor positive (hr+) her2-negative stage ii and iii breast cancer in real clinical practice in russia

Conditions: Breast Cancer

Summary: this prospective, observational, multicenter study aims at evaluating the efficacy of adjuvant ribociclib in combination with hormone therapy (aromatase inhibitor ± gnrh aginost) in various subgroups of patients with hr+her2- stage ii-iii breast cancer in real clinical practice in russia. subgroup division will be based on the tumor grade, lymph node involvement, and the response to test hormone therapy. the study will consist of two cohorts: a prospective one with patients receiving adjuvant therapy with ribociclib combined with aromatase inhibitors (ai), and a retrospective one with patients receiving adjuvant therapy with ai alone. thus, both primary data collection and secondary use of data will be organized.


Eligibility criteria:
inclusion criteria: patients from the prospective cohort of the study must meet all of the following criteria: 1. signed and dated informed consent form (icf) not later than 28 days after the initiation of adjuvant therapy with ribociclib in combination with aromatase inhibitors (±gnrh agonists). 2. age ≥18 years at the time of signing the icf. 3. histologically verified hr+ her2-negative stage ii-iii breast cancer, for which radical treatment was carried out. 4. the adjuvant hormone therapy with aromatase inhibitors (±gnrh agonists) may be started not earlier than 12 months before initiation of therapy with ribociclib. 5. ecog performance status 0-1 patients from the retrospective cohort of the study must meet all of the following criteria: 1. age ≥18 years at the initiation of hormone therapy. 2. histologically verified hr+ her2-negative stage ii-iii breast cancer, for which radical treatment was carried out. 3. initiation of adjuvant hormone monotherapy with aromatase inhibitors (±gnrh agonists) in the index period from july 1, 2019 to july 1, 2020. 4. presence of the necessary information in the source documentation. exclusion criteria: patients enrolled in the study in prospective cohort should not meet any of the following criteria. 1. history of therapy with abemaciclib or palbociclib 2. therapy with ribociclib in combination with ai for more than 28 days at the time of signing the informed consent form 3. active therapy for other malignant neoplasms 4. participation in interventional clinical studies at the time of signing the informed consent form patients enrolled in the study in retrospective cohort should not meet any of the following criteria. 1. neoadjuvant or adjuvant therapy with cdk4/6 inhibitors 2. a history of another concomitant malignant neoplasm requiring active therapy 3. participation in interventional clinical studies at the time of treatment for breast cancer 4. patients experiencing a recurrence during adjuvant hormone therapy can participate if they meet the other inclusion and exclusion criteria.

Keywords: breast cancer
left bundle branch area mapping for conduction system pacing

Conditions: Left Bundle-Branch Block; Pacemaker DDD

Summary: this study will utilize 3d mapping as a tool to explore electro-anatomical and electrocardiographic characteristics of the left bundle branch area. we plan on prospectively reviewing the data found from 3d mapping the left bundle branch implantation cases and using the data to improve understanding of electro-anatomical characteristics of this area for a better definition of the implantation target and depth.

this is an observational study that will provide the data for further hypothesis generation and confirmation in a larger study. we will define and record electro-anatomical characteristics of the interventricular septum and surrounding areas. several electro-anatomical characteristics will be measured during the lead placement into the left bundle branch area. mapping will be performed with the pacing lead. we will collect electrocardiographic markers of successful and unsuccessful lbba pacemaker implantation attempts and correlate them with electro-anatomical information.

Eligibility criteria:
inclusion criteria: * 30 consecutive patients ages 18 through 88 that undergo left bundle branch area pacemaker implantation. exclusion criteria: * recent mi-less than 3 months * recent percutaneous coronary revascularization-less than 2 weeks * recent open-heart procedures (cabg, valvular procedures, etc.)-less than 1 month * patients who are acutely ill and unstable, from the investigator's perspective, but require an urgent permanent pacemaker

Keywords: left bundle branch block pacemaker physiologic stimulation
effects of salsalate on prandial-induced vascular inflammation after spinal cord injury (sci)

Conditions: Spinal Cord Injury

Summary: the overall study objectives are to examine whether: 1. persons with spinal cord injury (sci) having elevated body mass are at greater cardiovascular disease (cvd) risk for fasting and postprandial lipidemia, glycemia, and vascular inflammation than persons with sci having 'normal' body mass, and 2. an inexpensive, low-risk, widely-available pharmacotherapy safely reduces cvd risks associated with fasting and postprandial lipidemia, glycemia, and vascular inflammation.

to test study objective 1, 'overweight' and 'non-overweight' persons with sci will be compared at baseline for fasting and postprandial responses. for study objective 2, all persons tested for study objective 1 will undergo randomization to either 1 month of salsalate (4.0 g/day) or placebo. an untreated wash-in (1 month) will precede treatment (1 month), and a washout cross-over period (1 month) will follow. the last month will test effects of drug-placebo not examined in month 2. fasting and postprandial responses will be tested at each time point. intention-to-treat clinical standards ("...as randomized, so analyzed...") and 'last observation carried forward' clinical methods will be adopted. participants with tetraplegia are sought, as they have fewer exercise options than those with paraplegia and are at greater risk for sedentary lifestyle resulting in cvd, cvd risks, and obesity.

Eligibility criteria:
inclusion criteria: * sci resulting in tetraplegia at c3-c7 * injury for more than one year exclusion criteria: * 1. any recent dietary or other lifestyle changes; * 2. diabetes or inflammatory medical conditions; * 3. a pressure ulcer; * 4. lung or bladder infection; * 5. undiagnosed illness or fever; * 6. recent surgery; * 7. stomach ulcer or a history of stomach upset when taking aspirin or medicines like aspirin, or , * 8. currently taking medicines used for pain or inflammation (aspirin and non-steroidal anti-inflammatory drugs, corticosteroids), blood vessel diseases (statins or fibric acid derivatives), blood clotting disorders (coumadin, plavix), infections (antibiotics), diabetes (metformin), and burning 'central' pain (voltage regulators).

Keywords: cardiovascular risk
long-term daily use of trazenta® tablets in patients with type 2 diabetes mellitus

Conditions: Diabetes Mellitus, Type 2

Summary: study to investigate the safety and efficacy of long-term daily use of trazenta® tablets as monotherapy in patients with type 2 diabetes mellitus and to assess baseline characteristics of patients with type 2 diabetes mellitus starting trazenta® tablets or any other oral antidiabetic monotherapy (naïve or switched from prior therapy of different oral antidiabetic drug).


Eligibility criteria:
inclusion criteria: * male and female patients with type 2 diabetes mellitus who have never been treated with trazenta tablets / linagliptin (monotherapy) before enrollment. (trazenta group) * patients with type 2 diabetes mellitus starting any other oral antidiabetic monotherapy (naïve or switched from prior therapy of different oral antidiabetic drug (oad)) except trazenta tablets. (oad group) exclusion criteria: none
compassionate use of omegaven to reverse parenteral nutrition induced cholestasis

Conditions: Cholestasis

Summary: the purpose of this research study is to see if giving omegaven (an intravenous fat emulsion containing fish oil) instead of the current lipid emulsion, which contains fat derived from soybeans, as part of your child's intravenous (iv) nutrition therapy may be tolerated better. it may reduce the harmful effects to the liver, may stop any further liver damage and may reverse damage already done to the liver because of the prolonged use of nutrition through your child's iv.

enrollment of subjects into this study will occur for up to 4 years. subjects will receive omegaven at a dose of up to 1 g/kg body weight/day until they no longer require total parenteral nutrition or until their conjugated/direct bilirubin has normalized and their enteral lipid intake is sufficient to discontinue intravenous lipids.

Eligibility criteria:
inclusion criteria: * males and females ages one month of age to 18 years of age * patients with intestinal failure on tpn * patients who have a conjugated/direct bilirubin of ≥3 mg/dl for more than weeks and in whom other causes of cholestasis have been excluded with reasonable certainty utilizing biochemical, serologic, microbiologic, and radiographic techniques. liver biopsy is not required to rule out other disorders, but may be utilized at the clinician's discretion * patients in whom reduction of iv soy-based lipid to an average \<1.2g/kg body weight/day has failed to reduce the conjugated/direct bilirubin within ≥ 30 days of implementation * willing to use birth control during study participation for females of child- bearing potential, as determined by investigator. * signed informed consent for use of omegaven® obtained exclusion criteria: * any of the contraindications to use of omegaven® * impaired lipid metabolism (triglycerides \>1000 mg/dl) while on 1g/kg/day or less of intralipid * history of severe hemorrhagic disorders (ie. hemophilia, von willebrand disease, etc.) * unstable diabetes mellitus * collapse and shock * stroke/ embolism * cardiac infarction within the last 3 months * undefined coma status * pregnancy (positive pregnancy test) prior to enrollment in the study for females of child-bearing potential * females of child-bearing potential who are unwilling to use birth control during study participation * parental decision to forego the use of omegaven® * known fish or egg allergy * pregnancy * causes of liver disease other than parenteral nutrition associated cholestasis

Keywords: parenteral nutrition cholestasis
early metabolic response in locally advanced esophageal cancer undergoing induction chemoradiotherapy

Conditions: Esophageal Carcinoma (Squamous Cell Carcinoma - Adenocarcinoma)

Summary: early metabolic response evaluation may predict clinical and histopathological response after neoadjuvant chemotherapy. its value in neoadjuvant chemoradiotherapy (crt) is unknown. our aim was to assess the value of early metabolic response after one cycle of chemotherapy using 18-fdg-pet-ct to predict pathological response and outcome in ct2-4 n0/+ esophageal cancer treated by neoadjuvant crt and esophagectomy.


Eligibility criteria:
inclusion criteria: * locally advanced esophageal cancer (ct2-4 n0/+) exclusion criteria: * pet-ct not performed at uzleuven * other tumor types * distant metastases (organ)
genetic study in young onset parkinson's disease

Conditions: Parkinson Disease

Summary: parkinson's disease (pd) is the second most frequent neurodegenerative disorder after alzheimer's disease. it causes motor dysfunctions, such as bradykinesia, resting tremor, rigidity and postural instability. although pd appears to be sporadic in most cases, several causative genes and susceptibility factors have been identified that cause familial forms of the disease with mendelian inheritance with autosomal dominant or autosomal recessive inheritance. approximately 5\~10% of patients with the clinical picture of pd carry a mutation in one of the known genes that cause monogenic forms of the disorder. the average age at onset is between 60 and 80 years and the average age of diagnosis is 60 years. onset of primary parkinsonism before 50 years is known as early onset parkinsonism(eop). onset between 20 and 50 years is known as young-onset pd. onset at younger than 20 years is known as juvenile parkinsonism (jp). at least, 13 loci and 9 genes are reported. the investigators study is aimed to screen the clinical diagnosed familial eop for the common mutation site by pcr/dna sequencing. the gene for screen are parkin (pattern: park2), pink1 (pattern: park6) and atp13a2 (pattern: park9).


Eligibility criteria:
inclusion criteria: * idiopathic parkinson's disease (according to uk parkinson's disease society brain bank clinical diagnosis criteria) * onset before 50-year-old or positive family history exclusion criteria: * secondary parkinsonism
effects of unstable shoes on trunk muscle activity, lumbar spine kinematics and pain in patients with low back pain

Conditions: Low Back Pain

Summary: aim: to compare trunk muscle activity, lumbar spine range of motion (rom) and lbp during gait using an unstable shoe (intervention group) and a conventional stable control shoe (control group). design: randomized controlled trial. setting: a biomechanics laboratory. population: patients with low back pain.

background: an unstable shoe was developed as a walking device to strengthen the lower extremity muscles and reduce joint loading. a large number of studies have reported increased electromyographic (emg) activity throughout the gait cycle in most of the lower limb muscles, and significant kinematic changes in the lower extremity. however, no studies have investigated the effects of wearing (1 month) unstable shoes on 1) spine kinematics, 2) trunk muscle activity and 3) low back pain (lbp) during gait in patients with chronic lbp. aim: to compare trunk muscle activity, lumbar spine range of motion (rom) and lbp during gait using an unstable shoe (intervention group) and a conventional stable control shoe (control group). design: randomized controlled trial. setting: a biomechanics laboratory. population: patients with low back pain.

Eligibility criteria:
inclusion criteria: * patients with chronic lbp * bmi \< 30 exclusion criteria: * hernia * lower limb pathologies * previous experience with unstable shoes

Keywords: unstable shoes;trunk muscles;lumbar lordosis;low back pain
docetaxel and cisplatin in treating patients with stage i, stage ii, or stage iii non-small cell lung cancer that has been completely removed by surgery

Conditions: Lung Cancer

Summary: rationale: drugs used in chemotherapy, such as docetaxel and cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. giving chemotherapy drugs after surgery may kill any tumor cells that remain after surgery. purpose: this phase ii trial is studying how well giving docetaxel together with cisplatin works in treating patients with stage i, stage ii, or stage iii non-small cell lung cancer that has been completely removed by surgery.

objectives: primary * compare the efficacy and safety of a new dosing schedule and dosing level of docetaxel and cisplatin with the chemotherapy regimens used in the international adjuvant lung cancer trial (ialt) in patients with completely resected stage ia-iiib non-small cell lung cancer. secondary * explore the relationship of time to recurrence, disease-free survival, and overall survival of these patients with levels of circulating dna and proteomic analysis of serum. outline: this is an open-label study. patients receive docetaxel iv over 30 minutes on days 1, 8, and 15 and cisplatin iv over 8 hours on day 15. treatment repeats every 28 days for up to 4 courses in the absence of disease progression or unacceptable toxicity. after completion of study treatment, patients are followed periodically. projected accrual: a total of 50 patients will be accrued for this study.

Eligibility criteria:
disease characteristics: * pathologically proven non-small cell lung cancer (nsclc) * stage ia-iiib disease * underwent prior complete surgical resection (r0) no more than 2 months ago * eligible for cisplatin-based adjuvant chemotherapy patient characteristics: * karnofsky performance status ≥ 70% * absolute neutrophil count ≥ 1,500/mm\^3 * hemoglobin ≥ 8.0 g/dl * platelet count ≥ 100,000/mm\^3 * creatinine clearance \> 55 ml/min * total bilirubin normal * alkaline phosphatase, ast, and alt must meet 1 of the following criteria: * alkaline phosphatase (ap) normal and ast and alt ≤ 5 times upper limit of normal (uln) * ap ≤ 2.5 times uln and ast and alt ≤ 1.5 times uln * ap ≤ 5 times uln and ast and alt normal * not pregnant or nursing * negative pregnancy test * fertile patients must use effective contraception during and for 3 months after completion of study treatment * no history of severe hypersensitivity reaction to docetaxel or other drugs formulated with polysorbate 80 * no peripheral neuropathy \> grade 1 * no hearing deficit at baseline, even if it does not require a hearing aid or intervention or interfere with activities of daily life (i.e., ctcae grade 2 or higher) prior concurrent therapy: * see disease characteristics * no prior postoperative radiation therapy * no prior chemotherapy for nsclc * no prior docetaxel or cisplatin * no concurrent prophylactic filgrastim (g-csf) or pegfilgrastim

Keywords: stage i non-small cell lung cancer stage ii non-small cell lung cancer stage iiia non-small cell lung cancer stage iiib non-small cell lung cancer
study comparing traditional and gender-specific total knee replacement designs

Conditions: Knee Osteoarthritis

Summary: the purpose of this study is to compare results obtained with gender-specific and traditional knee replacement systems design among women undergoing total knee replacement surgery. women who qualify and agree to participate will be randomly assigned to receive either a traditional or gender-specific knee replacement. during surgery, measurements of bone resection and bone-to-implant relationships will be recorded. at selected time intervals, participants will be asked to fill out questionnaires regarding pain and function, will be examined by their surgeon and routinely obtained xrays will be evaluated. in addition, a subset of participants will be randomly selected to undergo gait analysis to evaluate knee motion and muscle function.


Eligibility criteria:
inclusion criteria: * clinical diagnosis of end-stage degenerative joint disease of the knee * must be deemed appropriate for total knee replacement surgery exclusion criteria: * severe flexion deformity of the knee * greater than 20deg varus or valgus malalignment * osteomyelitis, septicemia, prior infection of the knee joint * presence of infections or highly communicable diseases * significant neurological or musculoskeletal disorders that affect gait or ability to bear weight on lower extremity * metastatic disease * congenital, developmental, bone disease or previous knee surgery that may interfere with the total knee prosthesis survival or success * previous total knee replacement in affected knee * arthrodesis of the affected knee

Keywords: total knee replacement gender specific design
single dose versus double dose tamsulosin in management of moderate and severe luts due to bph

Conditions: Prostatic Neoplasms; Prostate Disease; Prostate Obstruction; Prostate Hypertrophy

Summary: single dose versus double dose tamsulosin in management of moderate and severe lower urinary tract symptoms due to benign prostatic hyperplasia


Eligibility criteria:
inclusion criteria: * age more than 50 years * moderate to severe lower urinary tract symptoms exclusion criteria: * prostatic cancer * urethral stricture * prostate surgery * neurogenic bladder

Keywords: tamsulosin prostate
intraoral scanning accuracy in the edentulous mandible

Conditions: Jaw, Edentulous; Dental Impression Techniques

Summary: today, tooth- or implant-supported single crowns and short-span fixed partial dentures can be fabricated on the basis of an intraoral scan, but the scanning accuracy decreases with increasing length of the jaw section to be captured. an accurate scan is also made more difficult by edentulous jaw sections, as these provide the scanner with few landmarks for proper three-dimensional image composition. with respect to both edentulous and edentulous patients with dental implants, the currently available literature does not provide a firm basis for deciding whether such patients can already be scanned with sufficient accuracy. it is considered problematic in this context that the findings on digital impression accuracy, regardless of whether teeth or implants have been scanned, are based almost exclusively on the results of in vitro studies. conclusions about the accuracy of intraoral scanners under clinical conditions with moving patients and limited accessibility to the structures to be imaged, especially in the presence of blood, saliva or sulcus fluid, are extremely limited based on these data. therefore, the aim of this study is to determine the clinical scanning accuracy of two current intraoral scanning systems for the three-dimensional acquisition of the position of two interforaminal dental implants in the edentulous mandible. the influence of artificial landmarks to achieve increased scan accuracy will also be tested.


Eligibility criteria:
inclusion criteria: * participants who had received a mandibular overdenture supported by two implants with either locator attachments or a dodler bar attachment following an immediate loading protocol as part of a randomized controlled trial \[kappel s, giannakopoulos nn, eberhard l, rammelsberg p, eiffler c. immediate loading of dental implants in edentulous mandibles by use of locator® attachments or dolder® bars: two-year results from a prospective randomized clinical study. clin implant dent relat res. 2016 aug;18(4):752-61. doi: 10.1111/cid.12349. epub 2015 may 7. pmid: 25950679.\] and for whom intact working casts with laboratory implant analogs representing the reference implant positions were available. * participant is legally capable * signed informed consent form available exclusion criteria: * participant not contactable * participant not willing to participate * new overdenture or dolder bar attachment based on a working cast other than that used for immediate loading * no intact working casts available * diagnosed epilepsy * pregnancy and lactation * local or systemic acute or chronic (also in the past) general medical diseases and conditions, which contradict a participation in the study and or expose the patient to a higher risk in case of a study participation * known allergies or intolerances to the materials used in the study. * lack of compliance

Keywords: intraoral scan scanning accuracy edentulousness implant scan digital impression